United States Government Accountability Office Research Articles

Identifying and Addressing Basic Needs Insecurity Among Medical Students: A Curriculum for Trainees, Administrators, and Faculty.

IntroductionData from a 2018 United States Government Accountability Office report show that basic needs insecurity undermines the postsecondary educational experiences of many students. In recent years, basic needs insecurity among undergraduate students has gained attention in the literature, but published data regarding medical trainees are extremely limited.MethodsA 60-minute interactive workshop consisting of a PowerPoint presentation and case discussions was created. Our aim was to increase awareness and understanding of basic needs insecurity among medical students. The workshop included a basic needs survey and national and local resource guides. The workshop was evaluated through pre- and postworkshop questionnaires.ResultsThere were a total of 61 participants with diverse identities, including premedical and medical students, faculty, staff, and administrators. A comparison of pre- and postworkshop data showed increases in all knowledge-based questions, two of which were statistically significant. Most learners somewhat or strongly agreed the learning objectives were met. Participants positively commented on the interactive and collaborative nature of the workshop, the perspective the case discussions offered, and the tangible resources provided to them.DiscussionThis single session serves as a starting point to bring awareness that basic needs insecurity exists among medical trainees. It is a step toward a cross-departmental approach to assess the scope of the problem and find solutions to address it. Through the widespread implementation of this session, we hope participants can enact sustainable institutional changes that will support the basic needs of students.

Prevalence and Risk Factors for Intimate Partner Physical Violence-Related Acquired Brain Injury Among Visitors to Justice Center in New York.

The recent United States Government Accountability Office report highlights the need for improved data on the prevalence of intimate partner violence (IPV)-related acquired brain injury (ABI) to help direct Health & Human Services public efforts. This article identifies the prevalence and risk factors for IPV-related ABI among survivors of IPV at a Justice Center in New York. Community Justice Center. Forty survivors of IPV, aged 17 to 73 years (median 32, interquartile range: 25.25, 42) were assessed within 60 days of sustaining physical violence. Retrospective chart review. The HELPS and the Danger Assessment-Revised were used at the initial Center visit. Of the 40 physical IPV survivors screened, all (100%) reported a prior history of partner-induced ABI within the past 60 days. Thirty-seven (92.5%) survivors also reported sustaining at least 1 potential hypoxic brain injury from strangulation. However, only 16 (40%) survivors screened positive on the HELPS for a history of IPV-related mild traumatic brain injury. Females (95%) and individuals with low income (67.5%) largely comprised our sample. Compared with the County's average, the proportion of African Americans/Blacks and refugees was 227% higher (42.5% vs 13%) and 650% higher (7.5% vs 1.09%), respectively. Refugee status (P = .017) also correlated with number of previous ABIs. On an exploratory binary logistic regression with stepwise selection, only balance difficulties (P = .023) and difficulty concentrating/remembering (P = .009) predicted a positive screen for mild traumatic brain injury. Consistent with previous findings, our data indicate a high prevalence of IPV-related ABI among visitors to a New York Justice Center. An overrepresentation of African Americans/Blacks and refugees in our sample relative to the region signified a higher prevalence of IPV in these populations and warrants a provision of more trauma-informed ABI resources to these groups/communities. Intimate partner violence survivors visiting Justice Centers should be screened for motor/neurocognitive symptoms suggestive of mild traumatic brain injury. Further research to identify the prevalence and risk factors of IPV-related ABI statewide and nationwide is urgently needed to improve resource allocation and clinical management.

Prepayment risk in reverse mortgages: An intensity-governed surrender model

Reverse mortgages have been an important financial tool for cash poor seniors to release home equity. In the United States, most reverse mortgages are insured by the Federal Housing Administration (FHA) through the Home Equity Conversion Mortgage (HECM) program. Previous literature on reverse mortgage insurance often considers mortality as the main loan termination risk, and less attention has been paid to terminations due to loan prepayment, such as refinancing, repayment, and move-out. However, prepayment of reverse mortgages presents a significant risk to lenders and the HECM program. The Report to Congressional Requesters (United States Government Accountability Office, 2019) shows that about 28.5% of the total known reverse mortgage terminations in Fiscal Years 2014–2018 were attributed to loan refinancing, repayment, or move-out due to non-health reasons, whereas 48.6% of known terminations were attributed to mortality. In this paper, we employ an exogenous intensity-governed surrender model to study prepayment risk in reverse mortgages. The proposed model captures both macro-economic and non-economic drivers in surrender decisions. This paper complements existing studies of surrender behavior in reverse mortgages and provides a novel approach to incorporate prepayment risk into reverse mortgage pricing.

Evidence-Based Blockchain: Findings from a Global Study of Blockchain Projects and Start-up Companies

Evidence-based applications of resources remain one of the greatest challenges faced by governments, businesses, and policymakers. The United States Government Accountability Office (GAO) evaluated ten large programs, which together cost more than $10 billion/year, through randomised control trials – the highest standard of evidence-based practice (EBP). The evaluation found that nine of them had ‘weak or no positive effects’ on their participants. Many programs were not evaluated at all. In January 2019, U.S. President signed the ‘Foundations for Evidence-based Policy Making Act’ into law. A USAID (US Agency for International Development) study looked at 43 blockchain projects and companies claiming to have solved various problems using distributed ledgers. The study found that almost no company was willing to share their results and MERL (monitoring, evaluation, research and learning) processes. Other observational data revealed that 80–90% of blockchain-based token offering projects failed to deliver on their promises, a prediction also made by Vitalik Buterin, the founder of Ethereum blockchain, in 2017. The concept of evidence-based blockchain (EBB) was first introduced by Naqvi in 2018. We conducted an evaluation of 517 blockchain firms against PCIO framework of evidence-based practice: Problem – Comparison – Intervention and Outcomes. We define the fundamentals of EBB (Ask, Acquire, Appraise, Apply, Assess), provide a review of the literature on EBB, report findings of our study and propose an Assessment Framework of Evidence Based Blockchain.

Long-run equity performance of firms that restate financial statements

PurposeThe authors investigate how the stock market reacts to financial restatements using the restatements data from the United States Government Accountability Office (GAO-06-678). In particular, the purpose of this paper is to examine the long-run equity performance of the restating firms, for holding periods of one to five years after the announcements of restatements.Design/methodology/approachThis paper measures the long-run stock performance of restating firms with the buy-and-hold abnormal returns and time-series regression analyses based on Fama–French’s (1993) three-factor model and Carhart’s (1997) four-factor model.FindingsThe authors find that restating firms significantly underperform in the long run compared with their peers matched by industry, size and book-to-market. Restating firms’ underperformance is confirmed with time-series regression analyses based on Fama–French’s (1993) three-factor model and Carhart’s (1997) four-factor model. Further, the authors find the negative long-run abnormal performance of restating firms is primarily driven by large firms. The authors also report that self-prompted restatements and improper revenue accounting-triggered restatements result in worse long-run abnormal performance.Originality/valueThis paper is the first paper that thoroughly investigates the long-run stock returns of the firms that restate financial statements by fully considering the size effect.

What Works?

What Works? Alyson Cole (bio) and Victoria Hattam (bio) Click for larger view View full resolution Charlie Chaplin, Modern Times, 1936 © Roy Export SAS. Scan courtesy of Cineteca di Bologna. Worlds of work are changing. How polities respond remains a matter of consternation. Brexit, Donald Trump, Yanis Varoufakis, and Marine Le Pen signal a return to economic nationalism, while Xi Jinping, Justin Trudeau, and Angela Merkel pursue economic innovation in global terms. What forms will work and production take? Are global value chains still expanding, or have processes of economic reintegration set in? And what about jobs—do we need them? Are robots replacing human labor? Will we all be working for algorithms? The United States Government Accountability Office (GAO) estimates that 40.4 percent of the U.S. workforce is engaged in "contingent work" (2015, 4). To be sure, this estimate is high, since it relies on an expansive definition of contingency; nevertheless, there is broad agreement that temporary and other contingent labor is on the rise globally [End Page 15] (Katz and Krueger 2016; Kuruvilla, Lee, and Gallagher 2011). The European Political Strategy Center's (EPSC) "Future of Work," for example, is filled with new classifications for "alternative work arrangements"—temporary, agency, on-call, contract, independent, part-time, and freelance (2016, 3). Is this the "end of work" as we know it (Rifkin 1996), and should we celebrate or mourn that death? Or, as Mary Hawkesworth (2004) has cautioned, should we be wary of premature burials? What is clear is that we are witnessing the "feminization of labor" globally (Ngai 2016; Staudt 2011). In developing countries women constitute one-third of manufacturing jobs, in Asia they account for approximately half the industrial workforce, and in the Global South they represent the majority in agriculture. Women are also "more heavily concentrated than men in service jobs that provision the supply chains of global production" (Dunaway 2014, 1). Longstanding feminist concerns are thus reanimated: the relationship between home and work, the personal and political, and the public and private alters again, reshaping gendered divisions of labor. New insecurities reproduce and exacerbate older conceptions of devalued labor as always already raced, gendered, and inadequately remunerated. Still a contested neologism, some propose there is a new class formation, the "precariate" (Standing 2011; 2014; Milkman 2014). While many focus on growing inequality and the future contours of economic growth, Kathi Weeks (2011) and Miya Tokumitsu (2014) have argued, persuasively we think, that bringing everything back to work may be part of the problem rather than the solution. After all, increasing precaritization is bound up with other neoliberal mutations. States transfer responsibilities formerly under their purview to corporations, and corporations further erode benefits, job security, and pensions. Financialization reconfigures notions of subjectivity and citizenship, as well as the idea of "public things," from universities and libraries to even the White House (Ong 2006; Konings 2015; Brown 2015; Honig 2017). Do we require a profound reorientation to work? Should we question our love of work rather than worrying about who works, for what purposes, and at what price? How does precarity intersect with increased commitments to creativity and design as catalysts of growth? What would it mean to envision individual health beyond the metric of an ability to work and produce (Harvey 2000)? How might decentering work allow us to reimagine different political futures? These are the scenes, questions, and concerns that stimulated our interest in editing a special volume of WSQ [End Page 16] on precarious work. The articles, art, poems, and prose in this issue all explore the political work of precarity, and the precarity of work itself. "All That Is Solid Melts into Air": Feminae Precariae At first glance, precaritization or the precariate seem to rename alienated labor, exploited workers, and the destruction inherent to capitalist production. After all, the logic of capitalism, as Marx clarified in The Communist Manifesto (1872), relies on and reproduces volatility. The ambition for profit compels globalization in search of lower costs and new markets, which in turn demands a constant reconfiguring of the means of production, and with it, the social relations built upon them. It thus dismantles traditions, alters modes of exchange, disrupts social conditions...

Utilizing the Virtual Communication Sport-delivery Model to Promote Extracurricular Athletics for Students with Disabilities

In 2010, the United States Government Accountability Office (GAO) reevaluated the status of Public Law 93-112, Sec 504, which protects against discrimination solely based on someone's disability. Recommendations and findings were reported to school districts around the country in a document called the Dear Colleague Letter of 2013. The GAO identified several factors that limited opportunities for students with disabilities to participate in physical education and athletics, and produced several recommendations for school districts. One in particular stated that schools should consider offering separate or different athletic opportunities if reasonable accommodations were not providing effective participation of students with disabilities. However, constraints such as budget, logistics, coaches and facilities have affected these opportunities. This article features a creative sport delivery model — virtual communication — to address these constraints. This delivery option can be implemented across great geographical distances between several schools without the concern of travel, logistics or loss of time. Read how adapted physical educators developed and implemented a sport competition for Boccia across six different middle schools using virtual communication, thus providing a different athletic opportunity for students and at the same time addressing the recommendations identified in the Dear Colleague Letter.

Assessing, Documenting, and Accommodating ADHD in College Students

The prevalence of ADHD on college campuses has increased dramatically. From 2000 to 2008, the number of postsecondary students claiming ADHD as a disability nearly tripled, making it the fastest growing disability category on college campuses (United States Government Accountability Office [US GAO], 2009). Students with ADHD are now the second largest group of individuals with postsecondary disabilities requesting academic accommodations, representing over a quarter of this population (US GAO, 2011). There is strong reason to believe that the number of college students claiming ADHD as a disability will continue to grow, perhaps at an even quicker rate than it has over the past decade. The rate of high school students diagnosed with ADHD has also increased dramatically, particularly among adolescent boys, with nearly 1 in 5 diagnosed with ADHD (Visser et al., 2014). Further, the criteria for diagnosing ADHD in the recently released Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM5) have been loosened, likely increasing the probability that even more college students will seek disability services under the category of ADHD. In some ways, the dramatic increase in college students with ADHD may be perceived as encouraging, as postsecondary students with disabilities have historically been hesitant to selfidentify their disabilities and to seek accommodations (Newman et al., 2011). On the other hand, the sheer magnitude and pace of the increase in ADHD in college, along with troubling findings such as academic accommodations being disproportionately granted to those who are white, from upper class socioeconomic backgrounds, and from private schools (see Alfano & Boone, 2007, for a discussion of this issue), have led some to be skeptical of the complete legitimacy of the increased prevalence of ADHD among college students. The main way in which postsecondary institutions seek to legitimize disability claims for ADHD is to require students to submit documentation from a qualified professional substantiating such claims. Although ADHD documentation has been anecdotally reported to often be questionable and inadequate (e.g., Murphy, 2012), empirical investigation of ADHD documentation has been minimal. Recently, however, Nelson, Whipple, Lindstrom, and Foels (2014) empirically investigated reports by 100 psychologists that were submitted to document disability claims by college students who had been diagnosed with ADHD. The reports were coded to determine the assessment methods that were used, documentation practices that were included, and academic accommodations that were recommended. In the remainder of the current article, we highlight the promising and concerning findings from that study, and further discuss potential reasons for inadequate assessment and documentation practices, the importance of requiring reasonable documentation, and recommendations for improving the assessment and documentation of ADHD for postsecondary disability claims.

Lessons Learned by the Reporter: Is Disaggregation the Answer to the Asbestos Mess?

Described as an “elephantine mass” that “defies customary judicial administration,” asbestos litigation remains the longest-running mass tort in U.S. history. Ultimately, the efforts made to resolve the ever-expanding asbestos litigation failed. In 1997, in Amchem Products, Inc. v. Windsor, the United States Supreme Court struck down the use of a class action settlement to achieve a global resolution of all asbestos claims — those pending at the time and those of future claimants. In the wake of Amchem, dozens of asbestos defendants sought bankruptcy protection while plaintiffs continued to file claims in state and federal courts. Between 1988 and 2010, a United States Government Accountability Office (GAO) analysis of the approximately 100 bankruptcy trusts’ payment data showed that the asbestos trusts had paid about $17.5 billion to 3.3 million claimants. Since then, much has happened but basic problems remain. The patchwork system of plaintiffs claiming in federal and state courts, as well as the separate administrative claiming before bankruptcy trusts, raises complicated issues about how injured persons can be properly compensated while assuring that defendants are not assessed damages that are not warranted, and how to protect the trusts from fraud and preserve trust funds for future meritorious claimants.The American Bar Association Torts and Insurance Section appointed a Task Force to look into issues currently confronting asbestos stakeholders. I was appointed its Reporter. This Article focuses on how the Task Force went about its work and developed a record. It then presents some thoughts on how my service brought together my long-standing academic interest in how mass torts ought to be resolved and the realities of the current asbestos litigation. What I have learned thus far has led me to question my once zealous advocacy of aggregated mass tort claims resolution.When I served as Chairperson of the Dalkon Shield Claimant’s Trust, I wrote articles that focused on how the Trust resolved hundreds of thousands of claims. It is fair to say that I was a fan of aggregate resolution of mass torts. In my view, the use of multidistrict litigation, class actions, other aggregation tools, and even Chapter 11 reorganization provided fair and efficient vehicles for the resolution of mass torts. Indeed, the Dalkon Shield Board of Trustees expressly adopted motivating principles as they began to put meat on the bones of the CRF. First, and foremost, among these principles, was to “[t]reat all claimants fairly and equally, always focusing on the best interests of claimants collectively instead of on the interests of a particular claimant or group of claimants.” Another principle harkened back to the first: “Prefer settlement and prompt payment of claims over arbitration and litigation.” Rereading these principles in light of the compelling testimony of two of the Task Force witnesses challenged my weltanschauung about mass tort dispute resolution. Judge Robreno’s and Judge Davidson’s testimony about disaggregating cases into their core components, “letting lawyers be lawyers,” and getting cases ready for trial instead of obsessing about global or individual settlements is what led to the successful resolution of the cases before them.Moreover, Judge Robreno’s testimony suggests that attempts at aggregated resolution of the “elephantine mass” were all failures, except for the MDL itself, which has largely wrapped up its work. Rather, as Judges Robreno and Davidson testified, the disaggregation of asbestos claims allowed asbestos cases to be prepared for trial (or settlement discussions) more expeditiously. Now, dying plaintiffs can get a shot at a prompt trial date rather than having to wait out a global settlement. Perhaps tending to the needs of particular plaintiffs is the best way to protect the interests of the whole in mass tort litigation after all.

Preventing sexual attacks in healthcare facilities: Risk management considerations

Reports or allegations of sexual attacks in healthcare facilities are extremely upsetting and sometimes not given the attention they deserve. In June 2011, the United States Government Accountability Office (GAO) issued a remarkable report on sexual attacks occurring in Veterans Affairs (VA) health facilities that not only raised awareness of the magnitude of the problem but that detailed numerous system weaknesses in VA facilities that might have enabled such attacks. This article discusses some of the GAO's findings as well as other instances of sexual attacks, such as occurred in the criminal prosecution of Paul Serdula, a former health professional who might have sexually assaulted hundreds of women. Some of Serdula's victims have subsequently sued in civil court, charging Serdula's employers with lack of supervision and raising the possibility of serial sexual attacks such as his evolving into large-scale patient safety disasters. This article will review certain ethical and legal considerations bearing on the liability of healthcare facilities in which sexual attacks are alleged to have occurred. Following a discussion of how two courts have used the legal construct of "foreseeability" in determining a healthcare facility's liability when an employee is charged with sexual assault, the article will conclude with a host of patient safety recommendations aimed at discouraging or deterring the occurrence of sexual attacks.

Utilization of Interventional Techniques in Managing Chronic Pain in the Medicare Population: Analysis of Growth Patterns from 2000 to 2011

Background: Reports from the United States Government Accountability Office (GAO), the Institute of Medicine (IOM), the Medicare Payment Advisory Commission (MedPAC), and the Office of Inspector General (OIG) continue to express significant concern with the overall fiscal sustainability of Medicare and the exponential increase in costs for chronic pain management. Study Design: The study is an analysis of the growth of interventional techniques in managing chronic pain in Medicare beneficiaries from 2000 to 2011. Objective: To evaluate the use of all interventional techniques in chronic pain management. Methods: The study was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 to 2011. Results: Interventional techniques for chronic pain have increased dramatically from 2000 to 2011. Overall, the increase of interventional pain management (IPM) procedures from 2000 to 2011 went up 228%, with 177% per 100,000 Medicare beneficiaries. The increases were highest for facet joint interventions and sacroiliac joint blocks with a total increase of 386% and 310% per 100,000 Medicare beneficiaries, followed by 168% and 127% for epidural and adhesiolysis procedures, 150% and 111% for other types of nerve blocks and finally, 28% and 8% increases for percutaneous disc procedures. The geometric average of annual increases was 9.7% overall with 13.7% for facet joint interventions and sacroiliac joint blocks and 7.7% for epidural and adhesiolysis procedures. Limitations: The limitations of this study included a lack of inclusion of Medicare participants in Medicare Advantage plans, as well as potential documentation, coding, and billing errors. Conclusion: Interventional techniques increased significantly in Medicare beneficiaries from 2000 to 2011. Overall, there was an increase of 177% in the utilization of IPM services per 100,000 Medicare beneficiaries, with an annual geometric average increase of 9.7%. The study also showed an exponential increase in facet joint interventions and sacroiliac joint blocks. Key words: Interventional techniques, interventional pain management, facet joint injections, epidural steroid injections, sacroiliac joint injections, chronic pain, chronic spinal pain

Narrating the Non-Nation: Literary Journalism and "Illegal" Border Crossings

Narrating the Non-Nation:Literary Journalism and "Illegal" Border Crossings Marta Caminero-Santangelo (bio) The twenty-first century has been hailed as ushering in a new era of globalization and "post-nationalism," in which the nation-state is becoming an increasingly "obsolete" category (Appadurai 169). Such grand claims are belied, however, by the strong wave of resurgent nativism in the U.S. that has accompanied immigration reform debates of the last decade—most recently manifested in Arizona's notorious SB 1070 and similar legislative efforts in other states1—as well as by the accompanying escalation in "boundary enforcement" at the U.S.-Mexican border (Nevins 158-59). As immigration spiked to ever higher numbers in the 1990s and early 2000s in the wake of NAFTA, policy enforcement "crack-downs" suggested a new level of border policing. Operation Hold-the-Line in 1993 and Operation Gatekeeper in 1994 implemented more rigorous enforcement at highly populated points such as San Diego and El Paso, driving border crossers through less populous areas and harsh desert conditions (Eschbach 4, 9). These developments resulted in large numbers of immigrant deaths due to dehydration, suffocation, hypothermia, and hyperthermia. The United States Government Accountability Office reports that border crossing deaths as a whole more than doubled between 1995 and 2005, although this increase was not accompanied by a corresponding rise in illegal entries. In response, the last decade has seen a flurry of books on the subject of undocumented immigrant crossings and deaths including: Dead in their Tracks: Crossing America's Desert Borderlands (1999) by John [End Page 157] Annerino; Crossing Over: A Mexican Family on the Migrant Trail (2001) by Rubén Martínez; The Devil's Highway (2004) by Luis Alberto Urrea; Dying to Cross: The Worst Immigrant Tragedy in American History (2005) by Jorge Ramos; Enrique's Journey: The Story of a Boy's Dangerous Odyssey to Reunite With His Mother (2006) by Sonia Nazario; and The Death of Josseline: Immigration Stories from the Arizona Borderlands (2010) by Margaret Regan. These texts reframe the immigration debate through graphic narrative accounts of the human costs of our border policy, and they emphasize the pressing urgency of this crisis through the haunting leitmotif of border deaths. The title of this essay clearly takes its cue from Homi Bhabha's postulation that "nation" (understood as a sense of collective peoplehood that is geographically bounded and claims the right to sovereignty) is brought into being largely by stories, including shared histories and myths as well as "literature." Because stories of nation generally strive for a sense of homogeneity, they inevitably obscure or leave out elements that do not easily fit into the "imagined community" (Benedict Anderson's famous coinage) of the nation. The now standard labeling of undocumented immigrants as "illegals" in mainstream media suggests the degree to which this population has been narratively constructed as not fitting into the boundaries of the American "nation"—indeed, as fundamentally threatening that nation. Perceptions of Latinos as a national threat, Leo R. Chavez argues, have been shaped by "a history of ideas, laws, narratives, myths, and knowledge production in social sciences, sciences, the media, and the arts" that constitute a powerful set of "discursive formations" (22; Hall 6, qtd. in Chavez). In the wake of 9/11, titles linking immigration to threats to America's national security and even survival have proliferated.2 The authors of the border-crossing texts that I examine here clearly seek to intervene in this strident narrative of immigration as a threat to the existence of the nation by offering alternative narratives in which undocumented people are not imagined, first and foremost, as "aliens." These texts offer counter-discourses, reframing the story of immigration in terms that tend to shift the focus from the borders of "our" imagined community, to construct alternative notions of ethical communities. As works of literary journalism, these accounts capitalize on a culture in which "life narratives" have become not only instrumental in discourses on human rights, but also eminently marketable (Schaffer and Smith 7, 25, 27). [End Page 158] The current popularity of life writing suggests the degree to which these books might be instrumental in advocacy by reaching...

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.

Gestão estratégica de recursos públicos: avaliação das variáveis restritivas à efetividade na execução do Programa de Saúde da Família

O objetivo deste artigo consiste na avaliação das variáveis restritivas à efetividade do Programa de Saúde da Família (PSF) e na proposição metodológica orientada para a mensuração do desempenho com perspectiva de melhoria contínua deste programa. Para avaliação das variáveis utilizou-se o método de análise de conteúdo, aplicado em 197 relatórios da Controladoria Geral da União (CGU), período 2005-2007, confrontados com os princípios de controle do United States Government Accountability Office (GAO) e da Nova Administração Pública (NAP). Sendo que, para a análise da perspectiva de melhoria contínua com propósito de erradicação da ocorrência de tais tipos de variáveis, a metodologia sugerida à adoção foi o Activity Based in Cost (ABC). A hipótese vislumbrada com esta metodologia consiste em: no orçamento se admite a meta máxima de efetividade a partir da demanda dos serviços do PSF, enquanto que, na mensuração do desempenho a meta é a melhoria contínua do programa a partir da demanda de recursos. A pesquisa evidenciou a existência de variáveis restritivas à efetividade do PSF em 91% dos municípios auditados pela CGU. A falha mais frequente se refere à ineficiência na gestão dos recursos do programa.

Development and Application of a Database of Food Ingredient Fraud and Economically Motivated Adulteration from 1980 to 2010

Food ingredient fraud and economically motivated adulteration are emerging risks, but a comprehensive compilation of information about known problematic ingredients and detection methods does not currently exist. The objectives of this research were to collect such information from publicly available articles in scholarly journals and general media, organize into a database, and review and analyze the data to identify trends. The results summarized are a database that will be published in the US Pharmacopeial Convention's Food Chemicals Codex, 8th edition, and includes 1305 records, including 1000 records with analytical methods collected from 677 references. Olive oil, milk, honey, and saffron were the most common targets for adulteration reported in scholarly journals, and potentially harmful issues identified include spices diluted with lead chromate and lead tetraoxide, substitution of Chinese star anise with toxic Japanese star anise, and melamine adulteration of high protein content foods. High-performance liquid chromatography and infrared spectroscopy were the most common analytical detection procedures, and chemometrics data analysis was used in a large number of reports. Future expansion of this database will include additional publically available articles published before 1980 and in other languages, as well as data outside the public domain. The authors recommend in-depth analyses of individual incidents. This report describes the development and application of a database of food ingredient fraud issues from publicly available references. The database provides baseline information and data useful to governments, agencies, and individual companies assessing the risks of specific products produced in specific regions as well as products distributed and sold in other regions. In addition, the report describes current analytical technologies for detecting food fraud and identifies trends and developments.

After the GAO Report: What Do We Know About Public Election Funding?

In June of 2010, the United States Government Accountability Office (GAO) released a report that evaluates the effects of full public funding in Arizona and Maine. The report seeks to evaluate the policy effects of public funding in the states with regard to several stated goals of its supporters, including slower campaign spending growth, diminished interest group influence, enhanced political participation, and heightened electoral competitiveness. The GAO's paper is timely considering that full funding programs are becoming both more common and more visible to the public at large. The GAO's analysis contains several interesting findings, and its publication marks a good opportunity for political scientists and policy analysts to compare notes. Combining the contributions from each provides a more complete picture of what is known and unknown in the study of publicly funded elections. This article reviews the findings of the GAO report as well as those of a growing number of scholars who have examined the topic. It describes what the GAO, political scientists, and policy analysts have found with regard to public election funding, as well as opportunities that remain for further research. Where applicable, the article supplements this review with basic analysis of additional data. It should therefore be useful both for political scientists and the policy community.

United States Government Accountability Office: Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices

United States Government Accountability Office: Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices

United States Government Accountability Office Report on Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk

Nanotechnology involves the ability to control matter at the scale of a nanometer--one billionth of a meter. The world market for products that contain nanomaterials is expected to reach $2.6 trillion by 2015. In this context, the United States Government Accountability Office (GAO): (1) identified examples of current and potential uses of nanomaterials, (2) determined what is known about the potential human health and environmental risks from nanomaterials, (3) assessed actions the Environmental Protection Agency (EPA) has taken to better understand and regulate the risks posed by nanomaterials as well as its authorities to do so, and (4) identified approaches that other selected national authorities and U.S. states have taken to address the potential risks associated with nanomaterials. The GAO analyzed selected laws and regulations, reviewed information on the EPA's Nanoscale Materials Stewardship Program, and consulted with EPA officials and legal experts to obtain their perspectives on the EPA's authorities to regulate nanomaterials.

United States Government Accountability Office Report on Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk

United States Government Accountability Office Report on Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk

World laments loss of pathology service

A baby boy with growth the size of grapefruit on his neck has been brought by his parents to the Tamale Teaching Hospital in northern Ghana. Dr James Murphy, an ear nose and throat surgeon from New Jersey in the United States of America (USA), thinks the growth might be mass of blood vessels but he has no way of finding out. The hospital has no pathology department and there is no point in sending tissue samples to the capital city of Accra for diagnosis as they frequently get lost. In the past he would have sent the tissue sample to the free referral service run by the Armed Forces Institute of Pathology (AFIP) in Washington, DC, via the diplomatic bag of the United States embassy in Accra, but he has heard that this service is no longer available. Murphy, who has been working at the hospital for three years and is the sole otolaryngologist for an estimated 3 million people, is on his own. Usually he will not operate before baby is 10 weeks old but the situation becomes grave as the infant starts to have trouble breathing. A consultant in Accra advises him by telephone to inject an anticancer drug directly into the growth but instead he takes punt worthy of his 35 years of experience and operates. After the procedure he can see that the mass has the characteristics of teratoma, which is usually benign. [ILLUSTRATION OMITTED] Working without pathology services means taking an educated guess about what is wrong he says, sanguine about the life-and-death lottery of working in hospital in this part of Ghana, where people live on about US$ 3 day and most cannot afford to travel for biopsy. We get odd kinds of tumours here because of AIDS, he says. Patients who present to hospitals like the Tamale Teaching Hospital with tumours and unusual symptoms are the hidden casualties of the decision made by the United States Department of Defense to dose the AFIP. The decision, announced in 2005, has provoked little real protest, despite what many experts view as an incalculable loss to global public health. Murphy joined thousand or so signatories to an online petition to save the renowned institution. People signing this petition call the closure an irredeemable loss, travesty and worse, a grave error Such reactions are most likely too little, too late. The AFIP will close by September 2011 as part of federal programme to realign or close military bases. On 1 June, AFIP director Florabel Mullick announced that, after 30 September 2010, the institute will no longer accept non-federal civilian consultation cases. While the military will continue to collect pathology samples for its own purposes, doctors worldwide will no longer have the option of sending specimens for free second opinions. Their only option will be to use fee-based services, which is not feasible for doctors working in many developing countries. The institute, which is located at the Walter Reed Army Medical Center campus, was set up in 1862 by William Hammond, surgeon general of the United States Army, during the American Civil War to collect tissue samples for the military. The closure impacts the institute's international referral services, its renowned textbook series, training courses for pathologists, surgeons and radiologists worldwide and access for researchers to the world's most complete tissue repository, which contains 3 million specimens. The loss of access to this repository would mean that doctors would no longer be able to reference 150 years of case histories, 50 million glass slides, 30 million paraffin-embedded blocks of tissue and 12 million preserved wet tissue specimens. According to Paul Stone, spokesperson for the AFIP, many aspects of the closure are yet to be determined. In its 2007 report on the impact of dosing the AFIP, the United States Government Accountability Office said, Since AFIP receives pathology material for many difficult-to-diagnose diseases, the repository contains complex and uncommon cases that have accumulated over time. …